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Syndromic polymerase chain reaction (PCR)-based testing for lower respiratory tract infections leads to more rapid and targeted microbial treatment among patients with suspected community-acquired pneumonia (CAP), according to study results published in JAMA Network Open.
Syndromic testing is the process of simultaneously testing a patient for multiple pathogens that cause overlapping signs and symptoms.
Researchers conducted a pragmatic, parallel-arm, single-blinded, single-center, randomized clinical superiority trial (ClinicalTrials.gov Identifier: NCT04660084) to determine whether the use of a syndromic PCR-based panel for rapid testing of CAP results in faster and more accurate microbiological test result-based treatment. The trial was conducted between September 2021 and June 2022 at a large tertiary care hospital in Bergen, Norway. Patients enrolled in the trial were adults who presented to the emergency department with suspected CAP and had at least 2 prespecified pulmonary symptoms. Patients were randomly assigned 1:1 to undergo either rapid syndromic PCR testing plus microbiological testing (standard care) or standard care alone. Standard care consisted of blood cultures, pneumococcal urine testing, and in-house PCR testing.
The coprimary outcomes were the provision of pathogen-directed treatment based on a microbiological test result and time to provision of pathogen-directed treatment within 48 hours of group allocation. Cox proportional hazards regression and restricted mean survival time models were used to analyze the event-time primary outcome.
A total of 374 patients (median age, 72 [IQR, 60-79] years; men, 59.1%) were included in the analysis, with 187 assigned to each study arm. Overall, 97 patents in the intervention group and 103 in the standard care group were diagnosed with CAP.
Future research should continue to explore innovative approaches to improving the diagnosis and management of respiratory infections, such as incorporating clinical decision support tools and antimicrobial stewardship programs into routine practice.
Within 48 hours of group allocation, 66 (35.3%) patients in the intervention group and 25 (13.4%) in the standard care group received pathogen-directed treatment (absolute difference, 2.9%; 95% CI, 13.5-30.3). Between-group analysis indicated that the administration of pathogen-directed treatment was significantly more common among patients in the intervention group (odds ratio [OR], 3.53; 95% CI, 2.13-6.02; P <.001).
The median time to pathogen-directed treatment was significantly shorter among patients who received the intervention vs standard care (34.5 vs 43.8 hours; absolute difference, -9.4 hours; 95% CI, -12.7 to -6.0), corresponding to a hazard ratio (HR) of 3.08 (95% CI, 1.95-4.89; P <.001).
Further analysis between the groups showed similar findings among patients with confirmed CAP. The syndromic PCR-based panel was significantly associated with higher rates of pathogen-direct treatment (47.4% vs 15.5%; OR, 95% CI, 4.90; 95% CI, 2.57-9.77; P <.001) and reduced time to provision of pathogen-directed treatment (median, 29.9 vs 42.3 hours; HR, 3.45; 95% CI, 1.98-6.02; P <.001).
The median length of hospitalization was similar between patients assigned to the intervention vs standard care (3.3 [IQR, 2.0-6.0] vs 3.2 [IQR, 2.0-6.0] days; P =.67). In regard to clinical outcomes, patients in the intervention group were less likely to require hospital readmission (15.5% vs 18.7%; P =.41) but more likely to experience mortality within 30 days (4.8% vs 3.7%; P =.61) and within 90 days (8.6% vs 5.9%; P =.32).
The syndromic PCR-based panel resulted in a greater number of bacterial and viral detections in the overall population and among patients with confirmed CAP. In regard to safety, no severe adverse events were observed among patients in either group.
Study limitations include the single-center design and potentially inflated estimates of between-group differences as the trial was stopped prematurely for efficacy.
“Future research should continue to explore innovative approaches to improving the diagnosis and management of respiratory infections, such as incorporating clinical decision support tools and antimicrobial stewardship programs into routine practice,” the researchers concluded.
Reference
Markussen DL, Serigstad S, Ritz C, et al. Diagnostic stewardship in community-acquired pneumonia with syndromic molecular testing: a randomized clinical trial. JAMA Netw Open. 2024;7(3):e240830. doi:10.1001/jamanetworkopen.2024.0830